Pregnancy Monitoring Using Mobile Application

Sponsor
Gadjah Mada University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05741931
Collaborator
(none)
216
2
16

Study Details

Study Description

Brief Summary

The goal of this Randomized Controlled Trial is to compare the health condition of pregnant women through pregnancy monitoring in the implementation of pregnancy class. The main question it aims to answer are:

How is the condition of the mother and baby after pregnancy monitoring using the REST mobile application (Risk identification, Evaluation counseling, Systematic monitoring, Trobleshooting)

Participants will be monitored for the condition of their pregnancy from 20 weeks of pregnancy until delivery. Participants will attend in the pregnancy class as many as 3 meetings and a pregnancy check-up by the midwife.

Researchers will compare intervention group to see if normal delivery methods, birth weight of the baby (>2500), antenatal care visits (>6 times), and prevention of pregnancy complications were better than the control group.

Condition or Disease Intervention/Treatment Phase
  • Device: mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)
N/A

Detailed Description

The research will involve pregnant women and midwives. The midwife will conduct a pregnancy check-up which includes 10 pregnancy checks (height and weight, blood pressure, upper arm circumference, uterine fundus height, Tetanus immunization, Fe tablets, fetal presentation and fetal heart rate, counseling, laboratory tests, case handling). The examination is carried out every class meeting of pregnant women. The results of the examination will be inputted into the mobile application. Pregnant women will fill in the mobile application if the mother does antenatal care at a health facility. This activity will last until the mother's delivery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Monitoring Pregnant Women Using REST Mobile Application (Risk Identification, Evaluation Counseling, Systematic Monitoring, Troubleshooting)
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Pregnant women and midwives will use the REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) mobile application to monitor the condition of maternal pregnancy. Mothers and midwives will implementation 3 times of pregnancy class until mothers give birth

Device: mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)
The mobile application will be installed on the mobile phone. The application is used to monitor pregnant women. Users of the application are midwives and pregnant women. The application contains documentation of the health condition of pregnant women.

No Intervention: Control Group

Pregnant women and midwives will conduct pregnancy monitoring as usual. The pregnancy class will be implemented in accordance with government program standards. Mothers will take pregnancy class 3 times until the mother gives birth

Outcome Measures

Primary Outcome Measures

  1. Reduced incidence of pregnancy complications in the mother [20 weeks gestational age until delivery]

    Pregnancy complications are measured using a mobile application by looking at the history of the mother's health condition. Possible complications such as pre-eclampsia, eclampsia, hypertension in pregnancy, and anemia

  2. Increased childbirth by normal methods [20 weeks gestational age until delivery]

    The delivery method can be seen using the mobile application in the labor report section. Delivery will be reported by the midwife regarding the method used for childbirth including the results of filling out the partograph

  3. Reduced incidence of low birth weight babies [20 weeks gestational age until delivery]

    The baby's birth weight is measured using baby scales and it is expected that the baby's birth weight is more than 2500 grams

  4. Antenatal care for pregnant women more than 6 visits [During pregnancy]

    Antenatal care by mothers can be measured by the number of visits to health facilities for pregnancy check-ups. Each visit will be recorded on the mobile application starting from the first visit

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant women with a gestational age of 20-22 weeks.

  • Pregnant women who have a pregnancy check-up at a health facility

  • Plan to settle in the research area for at least the next 2 years

  • Willing to participate in the research by signing an informed consent form.

Exclusion Criteria:
  • Suffering from chronic diseases that require special pregnancy care

  • It is certain that it cannot give birth normally

  • Unable to operate an android phone

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gadjah Mada University

Investigators

  • Study Chair: Prima D Ratrikaningtyas, Gadjah Mada University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Restu Pangestuti, Principal Investigator, Gadjah Mada University
ClinicalTrials.gov Identifier:
NCT05741931
Other Study ID Numbers:
  • 485838
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Restu Pangestuti, Principal Investigator, Gadjah Mada University

Study Results

No Results Posted as of Feb 23, 2023